NCT03487354

Brief Summary

Medical abortion using multiple vs single daily dose of misoprostol in first trimester miscarriage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 25, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2019

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

9 months

First QC Date

March 25, 2018

Last Update Submit

January 26, 2019

Conditions

Miscarriage

Outcome Measures

Primary Outcomes (1)

  • Complete miscarriage

    Assessed by trans-vaginal ultrasound where endometrial thickness less than 15 mm is considered complete miscarriage

    one week

Study Arms (2)

Single daily dose

ACTIVE COMPARATOR
Drug: Misoprostol

Multiple daily doses

ACTIVE COMPARATOR
Drug: Misoprostol

Interventions

MisoprostolDRUG

Misoprostol

Multiple daily dosesSingle daily dose

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age more than 18 years old (age of legal consent).
  • Gestational age less than 13 weeks.
  • Hemoglobin \>10 g/dL.
  • BMI between 25 kg/m2 and 35 kg/m2.
  • Missed abortion.
  • Living fetus with multiple congenital malformations incompatible with life.

You may not qualify if:

  • Maternal age less than 18 years old.
  • Gestational age more than 12 weeks.
  • Hemoglobin \<10 g/dL.
  • Anencephaly.
  • Fibroid uterus.
  • BMI less than 25kg/m2 and more than 35kg/m2.
  • Coagulopathy.
  • History or evidence of adrenal pathology.
  • Previous attempts for induction of abortion in the current pregnancy.
  • Allergy to misoprostol or letrozole.
  • Medical disorder that contraindicate induction of abortion (e.g. heart failure).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2018

First Posted

April 4, 2018

Study Start

April 1, 2018

Primary Completion

January 10, 2019

Study Completion

January 10, 2019

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

EG(1)